No In The Supreme Court of the United States ALICE IVERS,

Transcription

1 No In The Supreme Court of the United States ALICE IVERS, v. Petitioner, WESTERLY PHARMACEUTICAL, INC., Respondent, On Writ of Certiorari From The United States Court of Appeals For the Twelfth Circuit BRIEF FOR RESPONDENT TEAM 2602 Counsel for Respondent

2 QUESTIONS PRESENTED I. Whether this Court s decisions in PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical v. Bartlett, 133 S. Ct (2013), preempt the Petitioner s claims in this case? II. Whether attorney s fees are considered awardable costs under Federal Rule of Civil Procedure 41(d) when a plaintiff changes forum jurisdictions following an adverse ruling in the first forum? i

3 TABLE OF CONTENTS QUESTIONS PRESENTED... i TABLE OF AUTHORITIES... v OPINIONS BELOW... 1 STATEMENT OF THE CASE... 1 SUMMARY OF THE ARGUMENT... 5 STANDARD OF REVIEW... 7 ARGUMENT AND AUTHORITIES... 8 I. THE TWELFTH CIRCUIT CORRECTLY HELD THAT THE FDCA PREEMPTS PETITIONER S CLAIMS UNDER THE ILLINOZA PRODUCTS LIABILITY ACT A. The Twelfth Circuit correctly held that it was impossible for Westerly to simultaneously comply with both state and federal labelling requirements... 8 i. Federal law and the FDA are the national authorities for drug safety standards ii. State law claims alleging failure-to-warn or label design defects are preempted by federal law iii. Illinoza s reasonableness requirement conflicts with the FDCA s requirement of sameness iv. Petitioner s claims are further preempted because the duties imposed by the Third Restatements of Torts, Federal law and the FDA are the national authorities for drug safety standards B. The Illinoza Products Liability Act is an obstacle to achieving the objectives of the FDCA and Hatch-Waxman Act i. The objective of the Hatch-Waxman Act is to create a streamlined Abbreviated New Drug Application process, making low-cost generic drugs more readily available to the public ii

4 ii. The Illinoza Products Liability Act impedes Hatch-Waxman s intent to provide the public with affordable medications C. Petitioner is not permitted to use Illinoza products liability claims as an end-run around preemption i. Petitioner s attempt to use state claims to enforce Westerly s compliance with the FDCA violates this Court s holding in Buckman. 27 ii. The Fifth Circuit correctly held that a failure-to-update claim sounds exclusively in federal law D. Westerly complied with all statutory and regulatory duties to update its ropidope label i. Westerly is entitled to safe harbor because it satisfied all label update requirements prescribed by the FDCA and Hatch-Waxman Act. 34 ii. Westerly s actions were reasonable under Illinoza Products Liability Law II. ATTORNEY S FEES ARE AWARDABLE COSTS UNDER FED. R. CIV. P. 41(d) A. The Court should adopt the holdings of the Fourth and Seventh Circuits that attorney s fees are awardable costs under Rule 41(d) i. The Fourth and Seventh Circuits have persuasively held that attorney s fees are awardable based on abusive conduct or when permitted by an underlying statute ii. This Court should reject the holding of the Sixth Circuit in Rogers v. Wal-Mart, as the circuit court erroneously relied on the absence of an express award of attorney fees in Rule 41(d) iii. The Sixth Circuit s holding in Rogers v. Wal-Mart Stores, Inc. is distinguishable from the present case iv. Awarding attorney s fees under Rule 41(d) would only chill bad faith litigation B. The Twelfth Circuit properly awarded attorney s fees to Westerly i. Petitioner s vexatious litigation and forum shopping justify the award of attorney s fees iii

5 ii. East Texas state law expressly permits the award of attorney s fees as a component of costs CONCLUSION APPENDIX A iv

6 United States Supreme Court Cases TABLE OF AUTHORITIES Alyeska Pipeline Service Co. v. Wilderness Society, 421 U.S. 240 (1975)... 37, 38 Buckman Co., v. Plaintiff s Legal Comm., 531 U.S. 341 (2001)... passim Byrd v. Blue Ridge Rural Elec. Co-op., Inc., 356 U.S. 525 (1958) Chambers v. NASCO, Inc., 501 U.S. 32 (1991)... 36, 37 Christianburg Garment Co. v. Equal Employment Opportunity Commission, 434 U.S. 412 (1978) Crosby v. National Foreign Trade Council, 530 U.S. 363 (2000)... 8 Erie R. Co. v. Tompkins, 304 U.S. 64 (1938) F.D. Rich Co., Inc. v. United States ex rel. Indus. Lumber Co., 417 U.S. 116 (1974) 39 Farmer v. Arabian Am. Oil Co., 379 U.S. 227 (1964) Fidelity Fed. Sav. & Loan Ass n v. de la Cuestra, 458 U.S. 141 (1982)... 8 Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 120 S. Ct (2000)... 9 Freightliner Corp. v. Myrick, 514 U.S. 280 (1995)... 8 Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861 (2000)... 8 Goodyear Tire & Rubber Co. v. Haeger, 137 S. Ct (2017)... 36, 45, 46 Hardt v. Reliance Standard Life Ins. Co., 560 U.S. 242 (2010) Hines v. Davidowitz, 312 U.S. 52 (1941)... 9, 20, 30 Marek v. Chesny, 473 U.S. 1 (1985)... 40, 43 Maryland v. Louisiana, 451 U.S. 725 (1981)... 8 Medtronic v. Lohr, 518 U.S. 470 (1996)... 9, 15 Mutual Pharmaceutical v. Bartlett, 133 S. Ct (2013)... 10, 11, 13, 14 Pierce v. Underwood, 487 U.S. 552 (1988)... 7 PLIVA v. Mensing, 564 U.S. 604 (2011)... passim Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) Salve Regina College v. Russell, 499 U.S. 225 (1991)... 7 Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015)... 7 Wyeth v. Levine, 555 U.S. 555 (2009)... 9, 14 v

7 Circuit Court Cases Andrews v. America s Living Centers, LLC, 827 F.3d 306 (4th Cir. 2016)38, 39, 40, 41 Chieftain Royalty Company v. Enervest Energy Institutional Fund XIII-A, L.P., 861 F.3d 1182 (10th Cir. 2017)... 40, 41 Davis v. USX Corp., 819 F.2d 1270 (4th Cir. 1987) Drager v. PLIVA, 741 F.3d 470 (4th Cir. 2014) Farmer v. Arabian Am. Oil Co., 324 F.2d 359 (2nd Cir. 1963) Fulgenzi v. PLIVA, 711 F.3d 578 (6th Cir. 2013)... 32, 33 Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013) Hutchison v. Staton, 994 F.2d 1076 (4th Cir. 1993) In re Darvocet, 756 F.3d 917 (6th Cir. 2014) Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605 (5th Cir. 2014) Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014)... 14, 15, 31 LeCompte v. Mr. Chip, 528 F.2d 601 (5th Cir. 1976) Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013)... 14, 19, 31 Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868 (6th Cir. 2000)... 41, 42, 44, 46 Simeone v. First Bank Nat l Ass n, 971 F.2d 103 (8th Cir. 1992)... 39, 40, 45 Federal District Court Cases Loreto v. Procter & Gamble Co., 737 F. Supp. 2d 909 (S.D. Ohio 2010) Robinson v. Neslon, No MLW, 1999 WL (D. Mass. Feb. 18, 1999) 46 State Court Cases In re Reglan Litig., 142 A.3d 725 (N.J. 2016)... 33, 35 Constitutional Provisions U.S. CONST. art. VI, cl Statutes and Session Laws 21 U.S.C vi

8 21 U.S.C U.S.C , 28, U.S.C , U.S.C passim E. Tex. Code Ann , 47 Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No , 52 Stat Pure Food and Drugs Act of 1906, Pub. L. No , 34 Stat Rules Fed. R. Civ. P Regulations 21 C.F.R , 16, 24, C.F.R C.F.R passim 21 C.F.R , 15 Abbreviated New Drug Application Regulations Final Rule, 57 Fed. Reg (Apr. 28, 1992) Secondary Sources Advisory Committee s Notes on the 1983 Amendment to Rule 11, 28 U.S.C.App., p Br. for the United States as Amicus Curiae in Supp. of Pet r. at 24, Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341 (2001) (No ) Correspondence from Jay P. Lefkowitz to Clerk, U.S. Supreme Court, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) Division of Generic Drugs, Policy, and Procedure Guide 8-89, Changes in the Labeling of ANDs Subsequent to Revision of Innovator Labeling, Aug , July 2013 FDA Guidance at p FDA Guidance for Industry, Revising ANDA Labeling Following Revision of the RLD Labeling, p. 1-2 (May 2000) Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study 4 (July 2002), available at vii

9 documents/reports/generic-drug-entry-prior-patent-expiration-ftcstudy/genericdrugstudy_0.pdf Generic Drug Savings and Access in the U.S., Association for Accessible Medicine at 5, sites/default/files/ /2017-aam-access- Savings-Report-2017-web2.pdf H.R. Rep. No , pt. 1, at (1984), reprinted in U.S.C.C.A.N. 2647, passim How did the Federal Food, Drug, and Cosmetic Act come about?, U.S. FOOD & DRUG ADMINISTRATION, 21 Julie Dohm, Expanding the Scope of the Hatch-Waxman Act's Patent Carve-Out Exception to the Identical Drug Labeling Requirement: Closing the Patent Litigation Loophole, 156 U. Pa. L. Rev. 151 (2007)... 35, 36 Laura Robinson, Analysis of Recent Proposals to Reconfigure Hatch-Waxman, 11 J. Intel. J. Prop. L. 47, 52 (2003)... 20, 21 Matric Global Advisors, Estimated Cost of FDA s Proposed Generic Drug Labeling Rule: Updated for (July 2016), Labeling.pdf OFFICE OF MGMT. & BUDGET, A NEW FOUNDATION FOR AMERICAN GREATNESS (2017), pdf Restatement of Torts, Third: Products Liability 6(d) (1998) Richard G. Frank, The Ongoing Regulation of Generic Drugs, 357 New Eng. J. Med (2007) viii

10 OPINIONS BELOW The opinion of the United States District Court for the District of Illinoza (No. AM CV) is unreported and is contained in the record. R. at 1-8. The opinion of the United States Court of Appeals for the Twelfth Circuit (No ) is also unreported and is set out in the record. R. at CONSTITUTIONAL AND STATUTORY PROVISIONS This case involves Article VI, clause 2 of the United States Constitution, the Food, Drug, and Cosmetic Act, and the Hatch-Waxman Act. Also at issue are the Illinoza Products Liability Act, the East Texas Products Liability Law, and the East Texas Code Annotated , which are set out in the record. R. at 3, 22. STATEMENT OF THE CASE Westerly Pharmaceutical, Inc., ( Westerly ) is a generic drug manufacturer providing Americans with low-cost medicines that are identical to their high-priced name-brand counterparts. R. at 1-2. Before any prescription drug can be marketed in the United States, it must receive approval from the Food and Drug Administration ( FDA ). R. at 4. The federal Food, Drug, and Cosmetic Act ( FDCA ), imposes strict standards on companies seeking to manufacture and sell new drugs to consumers. R. at 4. Included in these standards are how branded and generic drugs must be labelled and what warnings generic drug packing must contain. R. at 12. Once a new drug s patent expires, Title 21 U.S.C. 355(j) of the FDCA as amended by the Hatch Waxman Act permits a generic manufacturer to sell its drugs after an abbreviated review by the U.S. Food and Drug Administration 1

11 (FDA). R. at 4. Under the abbreviated review, a generic manufacturer must show that its drug is the bioequivalent of the branded drug and that its label will mirror the branded drug s label as required by 21 U.S.C. 355(j)(2)(A)(iv)-(v). R. at 4. A generic manufacturer has no discretion what to include in its label and is not allowed to alter the contents of its label unilaterally. R. at 5. A generic manufacturer may only update the contents of its drug s label after the branded drug has updated its own. R. at 5. A generic manufacturer s only duty is it to ensure that its label is the same as that of the branded drug s. R. at 14. In 1997, GlaxoCline, LLC ( GlaxoCline ) patented the drug ropidope hydrochloride ( ropidope ) which helps treat symptoms of Parkinson s disease. R. at 2. GlaxoCline received approval from the FDA to market ropidope as a new drug and began selling it under the brand name Equip. R. at 2. After GlaxoCline s patent expired in 2008, Westerly submitted the required Abbreviated New Drug Application ( ANDA ) to the FDA seeking approval to begin providing a more affordable, bioequivalent generic version to the public. R. at 2. In 2009, the FDA approved Westerly s ANDA with the condition that its labeling mirror the thencurrent label for Equip. R. at 2. Westerly followed FDA regulations and made its drug s label exactly match that of Equip s. R. at 2. In January 2011, GlaxoCline submitted a Supplemental New Drug Application ( snda ) to the FDA requesting approval of proposed changes to its labeling. R. at 2. The snda sought to add a new paragraph under the Warnings and Precautions section: 2

12 5.6 Impulse Control/Compulsive Behaviors Reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including EQUIP, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson s disease.... In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with EQUIP. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking EQUIP. R. at 2. Five months later, the FDA approved the request and GlaxoCline implemented the label change. R. at 2. Under the FDCA and Hatch-Waxman Act, Westerly was powerless to independently alter its ropidope label until GlaxoCline updated Equip s. R at 5. After GlaxoCline received approval for its label update, Westerly followed federal regulations and filed a Changes Being Effected (CBE) with the FDA in January 2012, notifying the FDA that it would be modifying the labels to include the newly-approved changes to match that of Equip. R. at 2-3, 14. One month later, Westerly updated its ropidope labels. R. at 3. Doctors diagnosed Petitioner Alice Ivers ( Petitioner ) with Parkinson s disease one month after GlaxoCline had submitted the proposed label changes to the FDA. R. at 1. As part of Petitioner s daily treatment, she began taking Westerly s affordable generic form of the drug in March R. at 1. This was three months before the FDA approved the label change for GlaxoCline s Equip. R. at 1. One month after the label change by GlaxoCline in June 2011, Petitioner 3

13 allegedly developed some of the side-effects described in the added warning paragraph including compulsive spending and gambling behaviors. R. at 3. Ms. Ivers states she felt compelled to spend money on charitable gifts and at antique auctions. R. at 3. During the next seventeen (17) months, Petitioner depleted her retirement savings. R. at 3. For ten (10) of those months, Westerly s label for its generic version included the updated warning. Petitioner, a resident of Cardozo, Illinoza, first filed a Complaint against Westerly, a Texas corporation, in the United States District Court for the Western District of East Texas on January 15, R. at 5. Petitioner asserted a claim under East Texas Products Liability Law and alleged that Westerly unreasonably failed to update its ropidope label. R. at 5, 11. Less than one month later, the Fifth Circuit Court of Appeals issued its opinion in Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013), which was adverse to Petitioner s position. R. at 5. Within eleven (11) days, Petitioner voluntarily dismissed her case against Respondent. R. at 5. Thirty-one (31) months later, Petitioner filed the instant Complaint in Illinoza state court based on the same facts and legal theories under the Illinoza Products Liability Act ( IPLA ). R. at 1. Ms. Ivers does not contend nor has ever claimed that Westerly did not update its ropidope label to match that of Equip. R. at 14. On October 14, 2015, Westerly timely and properly removed the case to the United States District Court for the District of Illinoza. R. at 1. Less than three weeks later, Westerly filed an answer to the complaint, a Motion for Judgment on 4

14 the Pleadings, and a Motion for an Award of Costs. R. at 3. The district court ruled in favor of Westerly on the Motion for Judgment on the Pleadings stating that Petitioner s state-law claims were preempted by federal law. R. at 5. Although the district court awarded $ in costs based on its discretion, the court held that Fed. R. Civ. P. 41(d) ( Rule 41(d) ) did not allow attorney s fees as awardable costs. R. at 6-7. On January 14, 2016, Petitioner appealed to the United States Court of Appeals for the Twelfth Circuit disputing the decision to dismiss the case and the award of any costs. R. at 11. The next day, Westerly filed a timely cross-appeal contesting the districts court s decision to not award attorney s fees as costs. R. at 11. The Twelfth Circuit affirmed the judgment on the pleadings and held that Petitioner s claims were preempted under both impossibility and obstacle preemption. R. at 12. The court further affirmed the award of $876.52, but also included Westerly s attorney s fees as costs, increasing awarded costs to $4, R. at 11, 18. Petitioner then filed this writ of certiorari which was granted on July 17, R. at 23. SUMMARY OF THE ARGUMENT All state law failure-to-warn and design-defect claims against generic manufacturers are preempted by the FDCA. Under this Court s holdings in PLIVA v. Mensing, 451 U.S. 725, 746 (2011) and Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466, 2473 (2013), state law claims that require generic manufacturers to strengthen their labels are preempted by the federal duty of sameness. Petitioner 5

15 claims that Westerly violated the IPLA by failing to strengthen its ropidope label reasonably. This is exactly the type of claim that is preempted under both Mensing and Bartlett. Even if it is found that Petitioner s claims are not preempted under Mensing and Bartlett, they should still be preempted as they stand as an obstacle to achieving the purpose and intent of the FDCA, as amended by the Hatch-Waxman Act ( HWA ). Congress enacted the HWA to remove the stringent approval requirements that have been placed on generic manufacturers so they could bring their low-cost drugs to market faster. Under the HWA, generic manufacturers must ensure that their drug matches their branded counterpart in all material facets. This is a generic manufacturer s sole duty under the HWA. The IPLA, however, imposes a reasonableness duty upon generic manufacturers to ensure that their drug s label matches their branded counterpart. As Petitioner s IPLA claims impose additional duties upon Westerly not contemplated by the HWA, they contravene the very reason Congress enacted the HWA. Although Petitioner couches her claims under Illinoza state law, the substance of her claims is rooted in federal law. Petitioner s failure-to-warn and design-defect claims are an attempt to enforce the federal labelling duties against Westerly. The federal duty to update is an essential element in the Petitioner s claims. This Court held in Buckman Co. v. Plaintiff s Legal Comm., 531 U.S. 341, 353 (2001), that when an essential element of a state law claim is premised on 6

16 federal law, it is preempted. As Petitioner s claims are preempted, this Court should affirm the Twelfth Circuit s judgment on the pleadings in favor of Westerly. Petitioner previously filed a similar claim against Westerly based on the same basic underlying facts. Following a precedential, adverse decision in that jurisdiction by the Fifth Circuit Court of Appeals, Petitioner voluntarily dismissed the action only to file a second Complaint in Illinoza state court beyond the reach of the unfavorable Fifth Circuit ruling. Using Rule 41(d), Respondent sought recovery of all costs for defending the first action including attorney s fees. Rule 41(d) permits the recovery of all or part of the costs of that previous action. The intent of the rule is to deter vexatious or bad faith litigation and forum shopping. Under Rule 41(d), attorney s fees are awardable costs when based on a party s misconduct or when permitted by an underlying statute. Petitioner s actions are exactly the type of conduct Rule 41(d) was designed to chill. Further, the applicable East Texas state law clearly provides that attorney s fees are considered a component of costs that can be awarded by the court. STANDARD OF REVIEW Any factual determinations by the lower court are reviewed on a clearly erroneous standard. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 836 (2015). The standard used for appellate review of questions of law is de novo. Salve Regina College v. Russell, 499 U.S. 225, 231 (1991). Matters of a court s discretion are reviewed under the abuse of discretion standard. Pierce v. Underwood, 487 U.S. 552, 558 (1988). 7

17 ARGUMENT AND AUTHORITIES I. THE TWELFTH CIRCUIT CORRECTLY HELD THAT THE FDCA PREEMPTS PETITIONER S CLAIMS UNDER THE ILLINOZA PRODUCTS LIABILITY ACT. The Supremacy Clause of the Constitution provides that federal law shall be the supreme Law of the land... Laws of any State to the Contrary notwithstanding. U.S. CONST. art. VI, cl. 2. State law that conflicts with federal law is preempted. Maryland v. Louisiana, 451 U.S. 725, 746 (1981). Congress can expressly preempt state law when the matter is within its authority. Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, (2000). Even in the absence of express language, state law is still preempted if Congressional intent to do so can be implied. Id. Preemption is implied when it is impossible for a private party to comply with both state and federal law, or when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. PLIVA v. Mensing, 564 U.S. 604, 634 (2011). This Court should find that Petitioner s claims are preempted as a result of both implied and conflict preemption. A. The Twelfth Circuit correctly held that it was impossible for Westerly to simultaneously comply with both state and federal labelling requirements. The FDCA made it impossible for Westerly to comply with the duties imposed by the IPLA. In Freightliner Corp. v. Myrick, this Court held that when state and federal law conflict, it is impossible for the party to adhere to both state and federal requirements. 514 U.S. 280, 287 (1995). [S]tate law is naturally preempted to the extent of any conflict with a federal statute. Crosby v. National Foreign Trade 8

18 Council, 530 U.S. 363, 372 (2000). Therefore, when the two laws conflict, the state law is preempted and nullified. Fidelity Fed. Sav. & Loan Ass n v. de la Cuestra, 458 U.S. 141, 153 (1982). In deference to federalism, a number of courts have applied a presumption against preemption when the issues concern matters that states have traditionally occupied, such as health and safety. Medtronic v. Lohr, 518 U.S. 470, 485 (1996). This Court has held, however, that when the issue is inherently federal in character, a presumption against preemption is not warranted. Buckman Co., v. Plaintiff s Legal Comm., 531 U.S. 341, 347 (2001). When Congress grants a federal agency police power over a field, the presumption shifts, and preemption is presumed. See Id.; Hines v. Davidowitz, 312 U.S. 52, 66 (1941). In the present case, the IPLA requires Westerly to perform duties in direct conflict with the FDCA, as amended by the HWA. Since the issue is inherently federal in nature, the Petitioner s state law claims are preempted. Buckman, 531 U.S. at 347. i. Federal law and the FDA are the national authorities for drug safety standards. It is well-settled that Congress granted the FDA sole authority to regulate the prescription drug industry in the United States. Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 120 S. Ct. 1291, 1297 (2000) (citing 21 U.S.C. 321(g)-(h)). The mission of the FDA is to provide for the protection of the public health by ensuring that... human and veterinarian drugs are safe and effective. In response to the growing concern that prescription drugs were unsafe and 9

19 fraudulently marketed, Congress enacted the FDCA in Wyeth v. Levine, 555 U.S. 555, 566 (2009)(citing 21 U.S.C. 301 et seq.). Under the FDCA, Congress empowers the FDA to regulate the sale, manufacture, and labelling of prescription drugs. 21 U.S.C. 355(a). The FDCA demands compliance by both branded and generic drug manufacturers. See 21 U.S.C. 355(a)-(h)(2)(viii). A drug must have FDA approval before it can be sold in the U.S. Id. For new brand name drugs, a manufacturer must submit a new drug application ( NDA ) with both clinical and nonclinical studies for FDA review. 21 U.S.C. 355 (b)(1)(a); 21 C.F.R (d)(2). Generic drug manufacturers are similarly policed, and are required to submit an ANDA which must include adequate information to show that its drug it identical to the branded drug in all material respects. 21 U.S.C. 355 (j)(2)(a). The FDA has discretion to either approve or deny the respective applications. 21 U.S.C. 355(d); 21 U.S.C. 355(j)(4(G). Under the FDCA and FDA regulations, the duties and obligations of branded and generic drugs are vastly different. Branded drugs must ensure that their labels are accurate and adequate. PLIVA v. Mensing, 564 U.S. 604, 613 (2011)(citing 21 U.S.C. 355(b)(1), (d)). In contrast, a generic manufacturer is not able or required to ensure the accuracy or adequacy of its label. A generic manufacturer s only duty is to make sure that its warning label matches that of the branded drug. Id. (citing 21 U.S.C. 355(j)(2)(A)(v), (j)(4)(g); 21 C.F.R (a)(8), 127(a)(7)). This is commonly referred to as a generic manufacturer s duty of sameness, which is 10

20 based on the FDCA s requirement that a generic drug must mirror or be the same as its branded counterpart s label. See id. at 613. ii. State law claims alleging failure-to-warn or label design defects are preempted by federal law. State law product liability claims alleging that a generic manufacturer s label failed to warn or is defectively designed are preempted by the FDCA. Mensing, 564 U.S. 604; Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466, 2473 (2013). In Mensing, this Court plainly held that state law failure-to-warn claims against generic manufacturers were preempted by FDCA and FDA regulations that require a generic drug to be the mirror image of its branded counterpart. See 564 U.S. at 624. Similarly, in Mutual Pharmaceutical v. Bartlett, this Court held that state law design defect claims against a generic manufacturer s label were preempted by the same laws and regulations. 133 S. Ct. at Allegations that a generic manufacturer violated state-law duties by failing to alter its FDA mandated warning label, are preempted. This Court in Mensing preempted all state law failure-to-warn claims against generic manufacturers in a practically identical set of facts as the present case. 564 U.S. at 613, The respondents in Mensing alleged that a generic manufacturer failed to provide an adequate warning label on its product. Id. at 610. The respondents took the petitioner s generic version of the drug metoclopramide, and later claim they developed side effects from its use. Id. The underlying products liability law of Minnesota and Louisiana required a generic manufacturer that is or 11

21 should be aware of its product s danger to label that product in a way that renders it reasonably safe. Id. If the allegations were true, both Minnesota and Louisiana laws demanded that the generic manufacturer use a safer label than what was used at the time the drugs were consumed. Id. at 611. Although the branded drug received approval from the FDA some years earlier to update its label, the Court was fully aware that the generic manufacturer did not update its label to match that of branded drug s subsequent FDA-approved label. Correspondence from Jay P. Lefkowitz to Clerk, U.S. Supreme Court, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). After examining the Supremacy Clause, this Court found that the clause indicates that a court need not look further than the ordinary meanin[g] of federal law, and should not distort federal law to accommodate conflicting state law. Mensing, 564 U.S. at 623. This Court made plain the nature and extent of federal preemption. [T]he Supremacy Clause therefore suggests that federal law should be understood to impliedly repeal conflicting state law. Further, the provision suggests that courts should not strain to find ways to reconcile federal law with seemingly conflicting state law. Id. at 622. When the ordinary meaning of the federal statute inhibits a party from doing what the state law requires, courts should find preemption. Id. at 623. In Mensing, this Court thus held that it was not lawful under federal law for the manufacturers to do what state law required of them update its label unilaterally. Id. at 617. The federal duty of sameness only requires that the generic 12

22 drug s label match the label of the branded drug. Id. at 618. Minnesota and Louisiana law demanded an updated label. Id. at 611. If, however, the generic manufacturer changed its label independently, it would have violated the federal duty of sameness. Id. at 618. The only action the generic manufacturer could take unilaterally was to ask the FDA for help, which is not a matter of state law concern. Id. at 624. Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same. Id. at 618Error! Bookmark not defined.. The Court recognized the unfortunate hand the respondents were dealt. Id. at 625. If the respondents had taken the branded drug, their suits would not be preempted. Id. However, since the respondents pharmacists gave them the generic version, federal law preempts their claims. Id. Although it was clear that the FDCA, as amended by the HWA, treats generic drugs significantly different than branded drugs, it is the special and different, regulation of generic drugs that allow the generic drug market to expand, bringing more quickly and cheaply to the public. Id. at 626. Though the Court recognized this disparate treatment, it still nevertheless held that any state law duty that requires a generic manufacturer to update its label unilaterally is preempted by federal law. See id. at In Mutual Pharmaceutical Co., Inc. v. Bartlett, this Court expanded its holding in Mensing and held that state law design-defect claims that require a generic manufacturer to strengthen its label are preempted by federal law. 133 S. Ct 2466, 2479 (2013). This Court was asked to decide whether a state law design- 13

23 defect claims requiring a generic manufacturer to ensure that its products were not unreasonably dangerous by either changing the drug s design or changing its label, were preempted. Id. at This Court swiftly dispensed with the redesign theory of liability, finding it would have required the generic manufacturer to violate the provisions of the FDCA which mandate that generic drugs have the same ingredients as its branded counterpart. Id. at 2475 (citing 21 U.S.C. 355(j)(2)(A)(ii) (v) and (8)(B); 21 C.F.R (c)). This Court further found that the state-law duty to strengthen the label to cure the defect was preempted under Mensing. Id. This Court has all but resolved the question of a generic manufacturer s liability under state law, stating, [a]s [Mensing] made clear, federal law prevents generic manufacturers from changing their labels. Id. A number of courts interpreting the holdings in Mensing and Bartlett have found that state law claims that turn on the adequacy of labeling are construed as failure-to-warn claims, and are preempted. Lashley v. Pfizer, Inc., 750 F.3d 470, 474 (5th Cir. 2014); Morris v. PLIVA, Inc., 713 F.3d 774, 776 (5th Cir. 2013). The plain language in Mensing and Bartlett supports this assertion. Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug s warnings are preempted by federal law under [Mensing]. Bartlett, 133 S. Ct. at No different result may otherwise be reached under the Supremacy Clause. There is no exception for generic drug manufacturers that fail to simultaneously update their labels to match those of the branded drugs. This Court made clear that generic manufacturers receive extra protection from state law 14

24 liability under the HWA. This Court previously decided in Wyeth v. Levine, that a brand name manufacturer remains liable under a state law failure-to-warn claim as the HWA does not prevent the brand name manufacturer from complying with the state law. 555 U.S. 555, Had the respondents in Mensing taken the branded drug, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits. Mensing, 564 U.S. at 625. Viewed in context, this Court established an either-or outcome for liability purposes: if a branded drug was taken, state law claims are not preempted; if a generic drug was taken, state law claims are preempted. As Petitioner clearly took a generic prescription drug, her claims are preempted in accord with this Court s holdings in Mensing and Bartlett. As the record shows, after Petitioner s doctor prescribed her ropidope, her pharmacist chose to fill Petitioner s prescription with the generic form of the drug. See R. at 1. The decision of Petitioner s pharmacist to fill her prescription with a generic drug removed any legal avenue for Petitioner to successfully assert her claims under Illinoza law. Petitioner s design-defect claim can easily be dispensed with to the extent it alleges a composition defect, as the federal duty of sameness requires a drug to be identical in composition to its branded counterpart. 21 U.S.C. 355(j)(2)(A)(ii) (v) and (8)(B); 21 C.F.R (c). Petitioner has not alleged a composition defect nor has she alleged that the physical content of Westerly s ropidope was in any way 15

25 different than that of Equip. The Twelfth Circuit correctly held that Petitioner s design-defect claim as it relates to labelling should be treated as failure-to-warn claim, and is therefore preempted under Mensing. See Lashley, 750 F.3d at 474; R. at 11, 15. As such, all of Petitioner s claims are preempted. iii. Illinoza s reasonableness requirement conflicts with the FDCA s requirement of sameness. In a preemption analysis, the purpose of Congress is the ultimate touchstone. Medtronic, Inc., v. Lohr, 518 U.S. 470, (1996). A [p]re-emption analysis requires [courts] to compare federal and state law. Mensing, 564 U.S. at 611. Here, the facts are clear. At issue is a claim against Westerly, a generic manufacturer. A generic manufacturer, like Westerly, only has a single duty under the present scheme of the FDCA: ensure that its drug label is the same as that of the branded drug. 21 U.S.C. 355(j)(2)(A)(v), (j)(4)(g); 21 C.F.R (a)(8), 127(a)(7)). Alternatively, Illinoza s Products Liability Act (1) is clearly preempted as it imposes additional compliance duties on generic drug manufacturers by requiring their label updates to be done reasonably. R. at 3. This added duty conflicts with a generic drug manufacturer s sole federal duty of sameness. Westerly is only required to show that it complied with the federal duty of sameness, not that it acted reasonably. Reasonableness is purely a matter of state law which has no grounds to operate in this particular federal regulatory scheme. Under the IPLA, a generic drug must ensure that its label is adequate and accurate. Id. (Which is nearly identical to the duties the HWA requires brand 16

26 name manufacturers to perform. 21 U.S.C. 355(b)(1), (d)). However, under the HWA, generic manufacturers cannot be required to conduct clinical trials. Therefore, a generic drug manufacturer cannot ensure that its label is adequate and accurate because it does not possess complete safety information. The HWA and the corresponding FDA regulations were implemented to allow generic drug manufacturers to bypass stringent procedural requirements that branded drugs were required to follow. H.R. Rep. No , pt. 1, at (1984), reprinted in U.S.C.C.A.N. 2647, The objective was to distribute their low-cost drugs more quickly, all to benefit the general public. Id. Any additional duty imposed on generic manufacturers other than the duty of sameness runs afoul with expressed Congressional intent. Moreover, as the Twelfth Circuit held, the IPLA s reasonableness standard does not account for the federally mandated process generic drugs must go through to change their labels. R. at 15. The IPLA does not parallel the FDCA and its amendments. Instead the ILPA imposes distinct additional duties on generic manufacturers, despite Congressional action to the contrary. Compare R. at 3 with H.R. Rep. No , pt. 1, at (1984), reprinted in U.S.C.C.A.N. 2647, If the IPLA merely supplemented the FDCA, an argument could be made that its provisions were parallel. Such is not the case. Under the IPLA, generic manufacturers face liability when they comply with the whole of federal law. If a generic manufacturer, like Westerly, complies with all duties imposed by the FDCA and updated its label properly, a state jury could still find the generic manufacturer 17

27 liable if it determined the generic manufacturer s actions were not reasonable by state law standards. Under the FDCA, a generic manufacturer may not be required to accept state law liability for simply complying with federal law. See Drager v. PLIVA, 741 F.3d 470, 476 (4th Cir. 2014). As a result, the Twelfth Circuit correctly held that the Illinoza state law duty of reasonableness inevitably conflicts with the federal duty of sameness, and is preempted. R. at 15. iv. Petitioner s claims are further preempted because the duties imposed by the Third Restatements of Torts, Federal law and the FDA are the national authorities for drug safety standards. To the extent that this Court does not find that all of the Petitioner s claims are preempted under Mensing and Bartlett, they are preempted due to Illinoza s general adherence to the Restatement of the Law, Third, Products Liability ( Restatement ). Although Illinoza has not explicitly articulated its standard for reasonableness in the prescription drug labeling context, it customarily follows the Restatement. R. at 15, n.7. The Restatement defines the failure to warn as follows: A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to: (1) prescribing and other [healthcare] providers who are in position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacturer knows or has reason to know the [healthcare] providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings. 18

28 Restatement of Torts, Third: Products Liability 6(d) (1998). The Restatement employs a reasonableness test to determine when a failure-to-warn is unreasonable. Id. The Restatement requires a manufacturer to notify prescribing physicians when foreseeable risks associated with taking the manufacturer s drug are not provided on the drug s label. As discussed herein, this unilateral action is preempted under Mensing. [I]f generic drug manufacturers, but not the brandname manufacturer, sent [letters to doctors], that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly misleading. Mensing, 564 U.S. at 615. The Fifth, Sixth, and Eleventh Circuits have all interpreted this holding to mean that even when a branded drug has updated its label, a generic manufacturer is barred by the federal duty of sameness from sending a warning letter to prescribing physicians if the branded drug manufacturer has not done so. Morris, 713 F.3d at 777; Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir. 2013); In re Darvocet, 756 F.3d 917, 933 (6th Cir. 2014). Under federal law, the inquiry is whether the brand-name manufacturer sent out a warning, not whether the proposed warning... contains substantially similar information as the label. Morris, 713 F.3d at 777. All three circuits held that the failure to communicate a warning to a doctor was preempted, as it was impossible to simultaneously comply with both the federal duty of sameness and the state law duty to warn. Id.; Darvocet, 756 F.3d at 933; Guarino, 756 F.3d at

29 In the present case, GlaxoCline did not submit a letter to doctors or patients concerning the foreseeable risks associated with taking Equip. If Westerly had sent letters to doctors or patients regarding its warning label in order to comply with Illinoza law, it would have violated the federal duty of sameness. Just as the circuits above, this Court should find that Petitioner s claims are barred under impossibility preemption. B. The Illinoza Products Liability Act is an obstacle to achieving the objectives of the FDCA and Hatch-Waxman Act. Even if this Court were to hold that it is technically possible to comply simultaneously with both the FDCA and the IPLA, the IPLA is still preempted because it acts as an obstacle to achieving the intent and objectives of the FDCA. State law, as here, is an obstacle when it acts as an impediment to achieving the full purposes and objectives of a federal law. See Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Wherein this Court stated, [a]nd where the federal government, in the exercise of its superior authority in [a] field, has enacted a complete scheme of regulation... states cannot, inconsistently with the purpose of Congress, conflict or interfere with, curtail or complement, the federal law, or enforce additional or auxiliary regulations. Id. at (emphasis added). Accordingly, this Court should find that the Twelfth Circuit correctly held that imposing the IPLA s reasonableness duty on generic manufacturers would frustrate the objectives of the HWA, and is thereby preempted. R. at

30 i. The objective of the Hatch-Waxman Act is to create a streamlined Abbreviated New Drug Application process, making low-cost generic drugs more readily available to the public. Before Congress enacted the HWA, the process required in order to approve generic drugs took years to complete. See Laura Robinson, Analysis of Recent Proposals to Reconfigure Hatch-Waxman, 11 J. Intel. J. Prop. L. 47, 52 (2003). A quick look at federal legislative history reveals that over the century, Congress intended prescription drug standards and regulations to be provided under federal law. See Pure Food and Drugs Act of 1906, Pub. L. No , 34 Stat. 768, repealed by Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No , 52 Stat Appalled that the prescription marketplace included a myriad of legal but dangerous drugs, Congress saw the need for stringent standards that would apply across the country to protect the public and enacted the FDCA. How did the Federal Food, Drug, and Cosmetic Act come about?, U.S. FOOD & DRUG ADMINISTRATION, In the early 1980s, Congress recognized the need to amend the FDCA as much of the public did not have access to affordable prescription drugs. As a result of the rigorous approval process for generic drug, branded drugs could maintain higher prices due as a result of lack of competition in the marketplace. Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study 4 (July 2002), available at Under the existing prescription 21

31 drug laws, generic drugs had to go through the same clinical studies as branded drugs before gaining FDA approval, and could not began the clinical studies until the branded drug s patent expired creating lengthy delays. See e.g. Laura J. Robinson, Analysis of Recent Proposals to Reconfigure Hatch-Waxman, 11 J. Intel. Prop. L. 47, 52 (2003). As a result, many Americans were without the financial means to purchase necessary prescription drugs. In response to the rising costs of brand name prescription drugs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No , 98 Stat (Sept. 24, 1984), commonly known as the Hatch- Waxman Act, to amend the FDCA and streamline the pathway so that more generic manufacturers could bring their drugs to market faster. H.R. Rep. No , pt. 1, at (1984), reprinted in U.S.C.C.A.N. 2647, Congress desired generic manufacturers to be free from the multitude of requirements and standards that prevented the public from accessible prescription drugs. Id. Under the revised process, after a branded drug s patent expire, all the generic manufacturer is required to do is submit an ANDA. The ANDA had to demonstrate that the generic version is a replica of a branded drug in all material respects. 21 U.S.C. 355(j)(2)(A). This provision allows generic manufacturers to avoid proving that its product is safe and effective because it is the bioequivalent of a branded drug. This allows generic manufacturers to take advantage of the branded drug s already rigorous approval process. 21 U.S.C. 355(b)(1) et seq. 22

32 The HWA achieved its goal. Before the Act was implemented, 81% of all prescriptions were filled by branded drugs. Richard G. Frank, The Ongoing Regulation of Generic Drugs, 357 New Eng. J. Med (2007). Today, 89% of prescriptions are filled by generic drugs. Generic Drug Savings and Access in the U.S., Association for Accessible Medicine at 5, sites/default/files/ /2017-aam-access-savings-report-2017-web2.pdf. Generic drugs provided patients and consumers savings of $253 billion in 2016, and $1.67 trillion over the past decade. Id. The savings are especially felt by individuals on Medicare or Medicaid: every Medicare enrollee saved an average of $1,883, while every Medicaid enrollee saved and average of $512. Id. Also, since Medicare and Medicaid patients were able to buy generics, the federal government saved approximately $114.9 billion. Id. (The projected discretionary budgets for the FY 2018 for the Education Department, HUD, and Department of Justice is $106.6 Billion. OFFICE OF MGMT. & BUDGET, A NEW FOUNDATION FOR AMERICAN GREATNESS (2017), f). Perhaps the most shocking statistic from the data is that, although generic drugs account for 89% of the prescriptions filled, they account for only 26% of the costs. Id. at 33. While branded drugs make up only 11% of the market, they account for $217.8 billion more in costs. Id. Because of the streamlined regulations and 23

33 duties, the HWA met its purpose and effect, providing millions of Americans access to life-saving drugs they would not otherwise be able acquire. ii. The Illinoza Products Liability Act impedes Hatch-Waxman s intent to provide the public with affordable medications. The IPLA s duty to make label updates reasonably, stands as an obstacle to achieving the intent and objectives of the HWA. Initially, as with impossibility preemption, to conduct obstacle preemption analysis courts must compare the federal and state law. Mensing, 564 U.S. at 611. The ANDA process required by the HWA was implemented to allow the public the ability to purchase low-cost generic drugs earlier. H.R. Rep. No , pt. 1, at (1984), reprinted in U.S.C.C.A.N. 2647, Conversely, the purpose of the Illinoza Products Liability Act (1), is to impose liability on a drug manufacturer when its product is unreasonably dangerous due to (a) manufacturing defect, (b) defective design, (c) inadequate instructions or warnings, or (d) failure to conform to express warranty. See R. at 3. If this Court allows generic manufacturers to be sued when they are unable to update one of their drugs at the same moment as the branded drug, state law juries have the power to eliminate the crucial benefits created by the HWA. The only duty Congress intended generic manufacturers to adhere to is the duty of sameness. See Mensing, 564 U.S. at 613 (citing 21 U.S.C. 355(j)(2)(A)(v), (j)(4)(g); 21 C.F.R (a)(8), 127(a)(7)). If Westerly is required to follow Illinoza s reasonableness standard, it would also to be required to adhere to every state s reasonableness standard. As soon as a branded drug updated its label, Westerly would have to ensure that its label update satisfied at least fifty-one (51) 24

34 standards. As label updates cannot be instantaneous, Westerly and other generic manufacturers would constantly be stuck in court. Any allegation that a generic manufacturer did not update its label reasonably or within a reasonable amount of time would survive motions to dismiss and summary judgment. As court costs and attorney fees amass upon the generic manufacturers like Westerly, the burden will inevitably be felt by the consumer and the federal government when the generic manufacturer is forced to raise its prices in order to remain viable. The obstacle Congress intended to be removed would breathe new life. Researchers predict that if generic drug manufacturers become liable for state law failure-to-warn claims, in 2017, it would cost patients an additional $5.6 billion a year in 2017 ($8.6 billion by 2024) to receive their medications. Matric Global Advisors, Estimated Cost of FDA s Proposed Generic Drug Labeling Rule: Updated for (July 2016), Labeling.pdf. And since jury standards vary by jurisdiction coupled with the fact there will be a new jury for each case, Westerly and other generic manufacturers will never know whether they have complied with state law when they make a label update. The addition of innumerable state law requirements would counteract the very reason Congress enacted the HWA: to make a streamlined, less costly path for generic manufacturers to efficiently bring their drugs to the public. See R. at 15. One additional standard would frustrate the intent of the HWA, let alone fifty (50) or more, and therefore should be preempted. 25